FemoSeal^® vascular closure device for antegrade common femoral artery access: Safety and technical notes

Abstract

Purpose: To retrospectively assess the efficacy and safety of FemoSeal® vascular closure device to achieve hemostasis following antegrade common femoral artery puncture after lower limb revascularization using vascular sheaths from 5 to 8 Fr. Methods: We reviewed the hemostatic outcome achieved with FemoSeal in 103 consecutive patients (mean age: 69 ± 8 years, 71 males) that undergone to 111 antegrade common femoral artery accesses for percutaneous lower limbs revascularization using 5- to 8-Fr vascular sheaths. We used FemoSeal in an unselected population, without exclusion criteria. The primary outcome was the technical success, meant as achieving complete hemostasis without immediate complications. Results: Hemostasis was achieved in all 111 puncture sites (100% technical success). We observed eight (7%) puncture site minor complications (hematomas), none of which affecting the patients’ outcome or requiring further therapies or increasing the hospital stay. There were no statistically significant differences between the variables potentially related to the occurrence of complications (age, international normalized ratio, platelet count, partial thromboplastin time ratio, body mass index, and common femoral arteries calcification grade) in patients with and without complications. Complications group mean body mass index was 26.4 ± 2.8 kg/m2 versus non-complications group 26.6 ± 4.4 kg/m2, p = 0.92. Mean international normalized ratio and partial thromboplastin time ratio were 1.05 ± 0.01 and 1.05 ± 0.14 versus 1.13 ± 0.2 (p = 0.39) and 1.12 ± 0.23 (p = 0.53), respectively. Common femoral arteries calcification grade was the same (mean: 1, p = 1). Platelet count was 202 × 103/mL ± 66.7 versus 226 × 103/mL ± 91.2, p = 0.55. Mean age was 72.3 ± 10 years versus 72.8 ± 8 years, p = 0.86. Conclusion: The low rate (7%) and grading of the adverse events, combined with the high technical success rate (100%), in an unselected group of patients treated in daily routine, suggest high safety and efficacy of FemoSeal vascular closure device in antegrade common femoral artery puncture site hemostasis when using vascular sheaths ranging from 5 to 8 Fr. Therefore, FemoSeal could be considered as a first-line hemostasis strategy in such cases.

Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System

“…After peripheral interventions, another study showed a success rate of the occlusion system independent of calcification [ 13 ]. Even after antegrade application of the FemoSeal system, calcification was not a predictor of complications [ 14 ].…”